Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1201 participants
INTERVENTIONAL
2006-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 85-89%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations.
Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
2
Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 91-95%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations.
Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
Interventions
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Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postnatal age \< 24 hours
Exclusion Criteria
* Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
* Known or strongly suspected cyanotic heart disease
* Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia
* Unlikely to be available for long-term follow-up
24 Hours
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Barbara Schmidt, MD
Role: STUDY_CHAIR
McMaster University
Robin Roberts, MMath
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences/McMaster University
Elizabeth Asztalos, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Alfonso Solimano, MD
Role: PRINCIPAL_INVESTIGATOR
Children's & Women's Health Centre of BC
Robin Whyte, MD
Role: PRINCIPAL_INVESTIGATOR
IWK Health Centre
Jack Rabi, MD
Role: PRINCIPAL_INVESTIGATOR
Foothills Hospital
Christian Poets, MD
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital Tuebingen
Locations
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Stony Brook University Medical Center
Stony Brook, New York, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania (HUP)
Philadelphia, Pennsylvania, United States
Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network
Buenos Aires, , Argentina
Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
B.C. Children's Hospital
Vancouver, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario and Ottawa General Hospital
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
CHU Ste. Justine
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Oulu University Central Hospital
Oulu, , Finland
University Children's Hospital
Tübingen, , Germany
Soroka University Medical Center
Beersheba, , Israel
Bnai-Zion Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Countries
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References
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Schmidt B, Whyte RK, Asztalos EV, Moddemann D, Poets C, Rabi Y, Solimano A, Roberts RS; Canadian Oxygen Trial (COT) Group. Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized clinical trial. JAMA. 2013 May 22;309(20):2111-20. doi: 10.1001/jama.2013.5555.
Schmidt B, Roberts RS, Whyte RK, Asztalos EV, Poets C, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Group. Impact of study oximeter masking algorithm on titration of oxygen therapy in the Canadian oxygen trial. J Pediatr. 2014 Oct;165(4):666-71.e2. doi: 10.1016/j.jpeds.2014.05.028. Epub 2014 Jun 25.
Jensen EA, Whyte RK, Schmidt B, Bassler D, Vain NE, Roberts RS; Canadian Oxygen Trial Investigators. Association between Intermittent Hypoxemia and Severe Bronchopulmonary Dysplasia in Preterm Infants. Am J Respir Crit Care Med. 2021 Nov 15;204(10):1192-1199. doi: 10.1164/rccm.202105-1150OC.
Other Identifiers
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MCT-79217/ISRCTN62491227
Identifier Type: -
Identifier Source: secondary_id
NTG-2006-COT
Identifier Type: -
Identifier Source: org_study_id
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